Glass Vials

• • Ongoing Z-2642-2024 FDA Class II ·initiated 3 Jun 2024

  During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.

510(k) Number

K811269 ↗

FDA Product Code

KPE

Device Class

Class II

Regulation

21 CFR Part 880.5025

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• 10CC Control Syringe

  Class II

  FDA 510(k) K873588 Active Cleared 23 Oct 1987

• Arterial-Venous Compression Dressing

  Not classified

  FDA 510(k) K851489 Active Cleared 11 Jun 1985

• I.V. Bottle (Ridgid) Open recall

  Class II

  FDA 510(k) K811234 Active Cleared 18 Jun 1981

• Fluoroscope Band Bag

  Class II

  FDA 510(k) K861785 Active Cleared 13 Jun 1986

• Operating Room Tray Set

  Class I

  FDA 510(k) K840021 Active Cleared 15 Mar 1984

• Heart Catheterization Tray Set

  Class II

  FDA 510(k) K840022 Active Cleared 4 Feb 1984

See all devices from Medi-Plast Intl., Inc. →

• Are these glass vials suitable for holding any type of intravenous medication, or are there specific types they’re designed for?

  These glass vials are designed for intravenous (I.V.) administration and are intended to hold liquids such as medications, vaccines, or other parenteral solutions. Since they provide a sterile, sealed environment, they are versatile for a wide range of I.V. formulations, but the specific compatibility depends on the contents—always verify the manufacturer’s instructions for the substance being stored.

• How do I know which size of these glass vials is right for my application, and are they available in multiple volumes?

  The vials are supplied in various sizes, though the exact volumes aren’t specified in the data. To determine the correct size, consider the volume of the liquid you plan to administer or store. Since they’re classified as intravenous containers, they’re likely available in common volumes like 1 mL, 2 mL, 5 mL, 10 mL, or 20 mL, but you may need to consult the manufacturer’s catalog or technical specifications for precise sizing options.

• Can these glass vials be reused after a single use, or are they strictly single-use only?

  The vials are explicitly labeled as single-use only, which is a key safety feature to prevent contamination and ensure patient safety. Reusing them could compromise sterility and integrity, so they should not be reused under any circumstances.

• How should these glass vials be stored to maintain their sterility and integrity before use?

  Since they are sterile and sealed, storage should follow standard medical device protocols: keep them in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging should remain intact until use, and they should be stored upright or in a position that prevents leaks or contamination. Always check the manufacturer’s guidelines for specific storage instructions.

• What regulatory pathway was followed for these glass vials, and how does that affect their use in clinical settings?

  These vials were cleared through the FDA’s 510(k) process (K811269) under product code KPE, classified as a Class II medical device. This means they meet FDA standards for safety and effectiveness as intravenous containers. Clinically, this clearance ensures they’re suitable for sterile, single-use I.V. administration in general hospital settings, but always verify compatibility with your facility’s protocols and the specific contents being administered.